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NCT Number: NCT06635434

An English/Spanish Mobile Augmented Reality Pain Assessment App for Hispanic/Latino Pediatric Cancer Patients

In this SBIR, ALTality, Inc. ("SpellBound") will assess the feasibility of a dual English/Spanish language augmented reality(AR)-enabled tool for assessing inpatient postoperative pain/nausea/vomiting in Hispanic/Latino children and adolescents with cancer in collaboration with bilingual Spanish-speaking anesthesiologists at the MD Anderson Cancer Center. If successful, the AR app will be an immediately implementable and commercially viable method of providing Hispanic/Latino pediatric cancer patients with limited English proficiency an adjunctive tool to overcome infrastructural barriers to receiving translation services in acute care settings that put them at higher risk of under and/or overtreatment of pain by prescription opioids and future prescription opioid dependency and misuse, at no cost to them or their families.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Pain Neoplasms Neurologic Manifestations Pathological Conditions, Signs and Symptoms Pediatric Cancer Signs and Symptoms

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

MD Anderson Cancer Center

Houston, Texas, 77054, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ages 7-17 years old
  • child able to provide assent, and a legal guardian able to provide informed consent
  • current diagnosis of pediatric cancer
  • undergoing surgery for cancer treatment requiring postoperative inpatient hospitalization
  • prescribed or expected to be prescribed opioids during inpatient perioperative period
  • sufficient mental capacity to comprehend and interact with the game in English or Spanish.

Exclusion criteria

  • the inability to play with the SpellBound app from English or Spanish instructions
  • daily opioid use within 30 days prior to surgery
  • any concerns from the treatment team.

Treatment and study plan

AR Pain assessment

Device

Age-stratified (age 7-11 and age 12-17 years old) augmented reality app to evaluate for pain and opioid-related adverse events with equivalent English and Spanish text, audio, and narration

Primary outcomes

  1. Primary; Percent of enrolled patients who activated/used the app during the PACU stay

    Time frame: immediately after the intervention/procedure/surgery

    Feasibility measured as activation/usage of the app recorded by the device ID for each patient

Secondary outcomes

  1. Total time spent playing on the AR app during the PACU stay

    Time frame: immediately after the intervention/procedure/surgery

    Length of time (minutes) of app usage recorded by the device ID for each patient

  2. Recorded responses about pain assessment from the app

    Time frame: immediately after the intervention/procedure/surgery

    Pain scale score in English or Spanish through the app

  3. Recorded responses about nausea/vomit assessment from the app

    Time frame: immediately after the intervention/procedure/surgery

    Baxter animated retching scale score in English or Spanish through the app

  4. Inpatient opioid consumption

    Time frame: immediately after the intervention/procedure/surgery

    Calculated as morphine equivalent dose of all opioids given

  5. Length of stay

    Time frame: immediately after the intervention/procedure/surgery

    Total time (minutes) spent in the PACU after surgery

  6. Quality of life survey

    Time frame: immediately after the intervention/procedure/surgery

    PedsQL survey administered to child and/or adult caregiver stratified by age

  7. Rate of opioid prescription

    Time frame: immediately after the intervention/procedure/surgery

    The percentage of patients with opioid prescriptions at the time of discharge from the electronic health record

  8. Patient/caregiver satisfaction survey

    Time frame: immediately after the intervention/procedure/surgery

    Asked to the patient/caregiver by the study team - 1) How satisfied were you with regards to your pain management in PACU?, 2) How satisfied were you with regards to your nausea management in PACU?, 3) How satisfied were you with the use of the AR app to help assess your pain and nausea?

Sponsors and collaborators

Lead sponsor

ALTality, Inc.

Industry

Collaborators

  • M.D. Anderson Cancer Center

Registry information

Official study title

Feasibility of a Dual English/Spanish Mobile Augmented Reality Pain Assessment App to Reduce Postoperative Prescription Opioid Use in Hispanic/Latino Pediatric and Adolescent Cancer Patients

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 10, 2024
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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